MAUDE Adverse Event Report: THERAKOS INC. THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Lot Number D310/329 - KIT

Device Problems Air Leak (1008); Fracture (1260)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/25/2015

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A review of kit lot d310 was performed.There were no nonconformances related to this complaint.This lot met release requirements.The uvadex lot number was not provided, since uvadex was not administered.However, a review of all uvadex lots manufactured since (b)(4) 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint categories, alarm #18: system pressure, air leak, and pressure dome membrane leak.A downward trend was identified for alarm #18: system pressure.No trend was identified for pressure dome membrane leak.A corrective and preventive action was initiated for complaint category, pressure dome membrane leak.Analysis of the returned photos is still in progress at the time of this report.A supplemental report will be filed when this analysis is complete.(b)(4).

Event Description

Clinical services educator on site reported blood leak at the collect pressure membrane after 1099 ml processed.Four system pressure alarms occurred starting at 850 ml processed.Air was noted in tubing at the instrument side of the collect pressure dome.Treatment was aborted after the leak was noted.Estimated blood loss was 210ml.Service was not requested.The customer sent pictures for investigation.

Manufacturer Narrative

Photos were returned for analysis.Based on the review of the photos, a leak at the collect pressure dome assembly was confirmed, not at the membrane, but at the joint between the pressure dome and the clear tubing from the pto.The root cause of the blood leak is likely a manufacturing operator error when forming the bond between the pto and the collect pressure dome, by not fully inserting the tubing.As part of the corrective action a quality notice was posted and trained to at the manufacturer on 4/29/15 to reaffirm solvent bonding at this site.Complaints of this nature are monitored through tracking and trending.Should a trend arise, further action will be taken.Based on the product return investigation, the complaint category was changed from pressure dome membrane leak to tubing leak.Trends were reviewed for complaint category, tubing leak, and no trends were detected.No corrective and preventive action was initiated for this complaint category.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS INC.; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave.; buffalo NY 14211
• Manufacturer Contact: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 5070629
• MDR Text Key: 26123030
• Report Number: 2523595-2015-00233
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: 10705030100009
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 02/01/2017
• Device Lot Number: D310/329 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 71